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Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease

StatusRecruiting
PhasePhase 2
Started2023-12-06
View on ClinicalTrials.gov ↗

Amendment history

2026-08-20
Study Status v15
Re-verified, no change to tracked fields
2026-06-03
Study Status, Contacts/Locations v14
Study sites4→5
2026-02-13
Study Status v13
Primary completion date2027-05-31→2028-04-30
Completion date2027-12-31→2028-11-30
2025-08-28
Study Status, Eligibility, Contacts/Locations v12
Study sites5→4
Eligibility criteria+109 characters
[...] 3 x upper limit of normal (ULN) Total bilirubin =< 1.5 x ULN, unless due to Gilbert's disease Glomerular filtration rate (GFRestimated glomerular filtration rate [eGFR]) >= 30 mL/min/1.73 m^2 Female subjects of childbearing pote [...] icides (creams or gel that contain a chemical to kill sperm); Surgical orsterilization (tubal ligation) A vasectomized partner For male subjects who are sexually a [...]
2025-05-22
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 5 sites
Show 10 earlier versions
2025-03-28
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v10
Eligibility criteria+76 characters
[...] evels is permitted, as are decreases in existing prednisone or prednisone equivalent dose based on routine clinical tapering practices. Increases in prednisone or prednisone equivalents are not allowed in the 2 weeks prior to enrollment Age 18 a [...] art of study medication 0.25 mg/kg/day or higher prednisone or prednisone equivalent dose at time of screening History of non-compliance that in [...]
Study description+28 characters
[...] oxicity. Patients undergo blood sample collection on study. Patients follow up afterAfter completion of study medicationtreatment, patients are followed up at 30 days, and at 60 days if 12 cycles are completed, and then up to 18 months.
Study sites5 entries, revised
Dana-Farber Cancer Institute
2024-11-19
Study Status v9
Re-verified, no change to tracked fields
2024-08-14
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 5 sites
2024-07-10
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 5 sites
2024-05-28
Study Status v6
Re-verified, no change to tracked fields
2023-12-27
Study Status v5
Start dateestimated 2023-12-20→confirmed 2023-12-06
2023-11-20
Study Status, Eligibility v4
Start date2023-12-01→2023-12-20
Eligibility criteria+35 characters
Inclusion Criteria: At least one diagnostic or distinctive cGVHD manifestation(s), with a clinical diagnosis of cGVHD,but patients do not need to meet National Institute of Healt [...]
2023-11-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2024-01-01→2023-12-01
Study sitesdetails revised at 5 of 5 sites
2023-10-18
Study Identification, Study Status v2
Re-verified, no change to tracked fields
2023-08-23
Study Status, Outcome Measures v1
Secondary endpoints3 entries, revised
RelapseRate of relapse
2023-08-10
Original filing
This phase II trial compares the effect of belumosudil to a placebo in treating patients with chronic graft versus host disease. Chronic graft versus host disease remains a major complication of stem cell transplantation and can involve multiple organ systems. Belumosudil is a ROCK2 selective inhibitor that works to reduce the immune system response causing the chronic graft versus host disease. Giving belumosudil may better treat patients with chronic graft versus host disease and prevent the need for starting additional immune suppressive medications.
Trial Details
NCT Number NCT05996627
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: Sanofi
Conditions Chronic Graft Versus Host Disease
Enrollment 82 participants
Start Date 2023-12-06
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-17